Sep 27
2010
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No. 25: What do PIs overlook the most when seeking IACUC approval of their protocols?Posted by: admin in Tagged in: Untagged
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RESEARCH COMPLIANCE
What do PIs overlook the most when seeking IACUC approval of their protocols?
Reader Question: I'm a new PI about to submit my first animal protocol to the Institutional Animal Care and Use Committee (IACUC) and am hoping to have it approved quickly. I've completed the application, but am afraid of overlooking something that will slow the process. Is there anything frequently overlooked to which I should give special attention?
Expert Comments: Watch out for hang-ups in safety reviews. That's perhaps the most common. For example, say you want to test a drug therapy in an animal or you expect to use a radioisotope. You'd likely need to pass a safety test in both cases and must do that before your IACUC will give your protocol its final approval.
We’ve found that many PIs don't research all of the preliminary requirements before submitting their proposals to the IACUC. Often there's more than one compliance administration within the institution whose blessing you need — for example, radiation or chemical-hazard safety.
Sometimes PIs aren't aware of this. As a result, the IACUC might have completed its review but the PI hasn't completed these additional steps. The IACUC usually won't put its final stamp on the project until there is proof of compliance across the board.
Your best bet is to take the following steps:
- Draw up a list of all the safety checks you’re going to need. If you have questions about any of them, contact the administrator for that area beforehand.
- Decide whether it’s wiser to submit them to each panel all at once or one at a time and build your time frame accordingly. For example, if handling the radiation-safety issue could alter your procedures so as to impact other parts of the process, then you’d want to take care of them individually. But it’s more likely that you’ll be able to secure all your safety approvals concurrently.
Expert comments: Judy Lassiter Schledorn, Regulatory Compliance Administrator, Institutional Animal Care and Use Committee, Sponsored Programs, and Regulatory Compliance, North Carolina State University.
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written by Attending Veterinarian, September 30, 2010
how people will be trained to perform the studies,
rationale for your animal numbers (we have always used X, is NOT an acceptable rationale).